Accenture Accelerated R&D Services combines our capabilities across strategy, consulting, digital, technology and operations to simplify and accelerate the journey from early research to regulatory approval and throughout the product lifecycle. We leverage our deep industry experience and customer insights to improve business outcomes and help our clients bring life-saving medicines to market.
- Provide strategic input into global regulatory plans for client taking into account commercial strategy, Health Authority (HA) regulations and guidelines, and issues or topics directly related to the project
- Maintain positive relationships with HA to facilitate and directly influence client interaction and support preparations and execution of successful meetings with HA
- Management of regulatory submissions, registration strategy and life cycle management and assistance with filings and approval processes in the US, EU and Emerging Markets
- Author, review and/or facilitate all types of documents that could be submitted to a HA to ensure submissions adhere to regulatory requirements
- Maintain global intelligence of product/project related HA regulations, submission guidance, recent approvals and precedents for client’s therapeutic area and/or assigned projects
- Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures
- Maintain established regulatory reputation through work with clients, HA and trade associations
- Provide internal training, mentoring and supervisory support to Regulatory Affairs and Operations staff
- Ability to lead a multidisciplinary project team across multiple geographic locations to build collaborative relationships with client, Health Authority and other experts in the regulatory field
- Establishes excellent working relationships with clients, peers and team members through integrity, credibility, reliability and trust
- Uses effective communication for one-on-one or small group conversations
- Promotes the professional growth of self and others to achieve individual and organizational goals
- Expertise in preparing and submitting all forms of regulatory documents
- Bachelor’s degree in natural science, life sciences or pharmacy; advanced degree is preferred
- Minimum 7 years of experience in pharmaceutical regulatory affairs, or equivalent industry experience
- Knowledge in handling registrations and maintenance of pharmaceuticals and/or biologics from a global & regional perspective and excellent international regulatory understanding
- Experience with a range of Clients and technology solutions which provides professional relevance
- Rich social benefit packages including: private medical care, Sodexo vouchers, Benefit sport club cards, life insurance
- Company car & petrol allowance
- New Joiners Programme including trainings
- Opportunity to engage in Corporate Social Responsibility initiatives
- We also think about your social life, at Accenture you will be able to take part in different initiatives like Book Club, International Cuisine Club, Accenture Runners Club, family events, cultural meetings, photography classes, climbing, soccer, swimming and many others
- Friendly work atmosphere in multicultural environment
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Accenture Sp. z o.o.
Accenture jest globalną firmą świadczącą usługi z zakresu konsultingu, nowoczesnych technologii i outsourcingu. Ponad 281 tys. pracowników Accenture świadczy usługi swoim klientom z ponad 120 krajów świata. Łącząc niezrównane doświadczenie, doskonałą znajomość wszystkich branż i funkcji biznesowych oraz rozległą wiedzę z badań nad najlepszymi firmami na całym świecie, Accenture współpracuje ze swoimi klientami, aby pomóc im stać się wysokoefektywnym przedsiębiorstwem.
W roku finansowym zamkniętym 31 sierpnia 2013 roku, Accenture osiągnęło przychody netto sięgające 28,6 miliarda dolarów. Strona internetowa firmy to www.accenture.com.